[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614499":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":59,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":10,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":86,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with Cirrhosis",null,"Cirrhosis and Portal Hypertension who are getting elective surgery or liver transplantation",[13],"Diagnostic Test: Assessment of microplastics in tissue",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Assessment of microplastics in tissue","After meeting inclusion and exclusion criteria, 30 patients with cirrhosis will be included in this study with written informed consent from patient (surgical cases) or scheduled liver biopsy. Diagnosis of chronic liver disease will be based on history, physical examination, laboratory investigations, upper gastrointestinal endoscopy as recorded in the patient file, imaging studies (ultrasonography and doppler of splenoportal venous axis). Underlying etiology of liver disease will be recorded. Complications of cirrhosis like hepatorenal syndrome (HRS), spontaneous bacterial peritonitis (SBP), upper gastrointestinal bleed, hepatic encephalopathy, acute kidney injury will be recorded from the patient's casefile.\n\nTissue Sample Processing Standard laboratory solvents (i.e., acetonitrile, methanol, and water (LiChrosolv and SupraSolv grade) will be procured. The contact of laboratory surfaces and equipment will be minimized to reduce the risk of background contamination by plastics.",[9],[21],{"name":22,"affiliation":23,"role":24},"Madhumita Premkumar","PGIMER Chandigarh","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Madhumita Premkumar, MD DM","CONTACT","01722754777","drmadhumitap@gmail.com",[32,49],{"facility":33,"status":34,"city":35,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Dr. Madhumita Premkumar","RECRUITING","Chandigarh","160012","India","IN",{"type":40,"coordinates":41},"Point",[42,43],76.7884,30.73629,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":48,"phoneExt":10,"email":30},"Dr. Madhumita Premkumar, MD","+919540951061",{"facility":23,"status":34,"city":35,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":50,"geoPoint":52,"contacts":53},{"type":40,"coordinates":51},[42,43],{"lat":43,"lon":42},[54,56,57],{"name":55,"role":28,"phone":29,"phoneExt":10,"email":30},"Prerna Premkumar",{"name":10,"role":28,"phone":10,"phoneExt":10,"email":30},{"name":58,"role":24,"phone":10,"phoneExt":10,"email":10},"Dr. Madhumita Premkumar, MD DM",{"type":24,"investigatorFullName":22,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Additional Professor of Hepatology",[62],{"name":63,"class":6},"Vellore Institute of Technology University","100614499","microplastics-cirrhosis-and-portal-hypertension-100614499",false,"NCT07280390","Microplastics, Cirrhosis and Portal Hypertension","The Impact of Microplastics and Nanoplastics on Liver Health and Cardiovascular Diseases in India","Inclusion Criteria:\n\n* Age range of 18-70 years\n* Cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings.\n* Undergoing elective surgery or liver transplantation\n\nExclusion Criteria:\n\n* • Hepatocellular carcinoma\n\n  * Pregnancy or lactation\n  * Patients with HIV or retroviral therapy\n  * Prior liver interventions like locoregional therapy, presence of HCC, prior abdominal surgery","ALL","18 Years","70 Years",{"count":75,"type":76},30,"ESTIMATED","OBSERVATIONAL","Cirrhosis and portal hypertension are associated with an hyperdynamic circulation and hepatic inflammation, leading to complications like ascites, variceal bleeding, acute kidney injury, and higher infection risk. Microplastics (MPs) are a global plastic pollution issue, and studies have found plastic MPs or nanoparticles (NPs) contaminating human, animal and environmental ecosystems.It has been noted that the accumulation of MPs increases with a reduction in size of the plastic particle. MPs are categorized into primary particles such as manufactured plastics including pellets and cosmetic microbeads and secondary particles which originate from mechanical and ultraviolet disruption of large plastic particles. MPs can be ingested via food or beverages, especially plastic packaged comestibles or inhaled as environmental pollutants. Contamination of medications such as antibiotics, intravenous fluids, albumin and medical devices is another source of exposure to microplastics in patients with chronic liver disease (CLD)In particular exposure to endoscopic interventions, liver biopsy, and invasive procedures such as paracentesis and interventional radiology procedures can lead to plastic exposure and deposition of MPs in the liver and other tissues in patients with cirrhosis. It may be hypothesized that these may contribute to hepatic inflammation and progression of cirrhosis and portal hypertension.\n\nGlobally, there is new research on the influence of MPs on the environment, plant and animal ecosystems and human health.\n\nPolystyrene (PS) microspheres that concentrate in the liver, intestine and the kidneys of mammals disrupt lipid and energy metabolism, impair mucus secretion, and alter the microbiome. Therefore, studies are required to assess how and to what extent, MPs impact human health, and affect chronic diseases like cirrhosis and reduce longevity.\n\nThe study investigators will assess the presence of MPs in the liver, kidneys and intestine of patients with liver cirrhosis and compare it with those without underlying liver disease and determine the impact on portal hypertension and fibrosis, and cardiovascular and metabolic function.",[80,81,82,83,84,85],"Cirrhosis","Microplastics","Portal Hypertension Related to Cirrhosis","Nanoplastics","Pollution","Cirrhosis and Chronic Liver Disease",[81,83,87,80,88],"Plastic pollution","Portal hypertension","2026-05-13",{"date":91,"type":92},"2026-05-15","ACTUAL",{"date":94,"type":92},"2026-05-01",{"date":96,"type":76},"2027-02-25",{"name":5,"class":6},2]